Kornimate/medical-research-clean huggingface dataset:
an adaptive design trial of gw274150 in the treatment of acute migraine

Conditions: Migraine Disorders; Migraine

Summary: nitric oxide (no) is likely to be involved in the development of migraine headache. nitric oxide synthase (nos) is an important chemical involved in the production of no. reduction of nos, and therefore no, may be an effective technique for the treatment of migraine headache. gw274150 is a highly selective inhibitor of nos and offers the potential of anti-inflammatory activity in migraine through a novel mechanism of action. the intent of this study is to investigate the safety and efficacy of gw274150 for the acute treatment of migraine headache.


Eligibility criteria:
inclusion criteria: * suffering from migraine with or without aura. * migraine for at least one year, and the age of onset was prior to 50 years. * consistent migraine headache over time and has had at least 1 migraine headache attacks but less than 15 days with headache (migraine or non-migraine) per month in each of the three months prior to the screening visit and maintains this requirement during the baseline period. * able to distinguish migraine headache attacks as discreet attacks from other headaches (i.e. tension-type headaches). * typically have moderate to severe migraine pain preceded by an identifiable mild pain phase. * no clinically significant abnormality identified on the medical or laboratory evaluation. a subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the doctor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures. * written informed consent prior to entry into the study. * females who are: a) non-childbearing potential or, b) of child-bearing potential, has a negative pregnancy test at screen, and is taken adequate contraceptive measures. exclusion criteria: * as a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study. * history of alcohol, substance or drug abuse within the last year. * taken a migraine prophylactic medication within 1 month of the screening visit. * uses an opiate as first line acute treatment for migraine attacks. * history of ergotamine, triptan, opioid, or combination medication intake on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months. * history of simple analgesic intake on greater than/equal 15 days per month for greater than/equal 3 months. * do not receive migraine relief from a triptan migraine treatment. * uncontrolled hypertension at the screening visit, defined as systolic blood pressure \>140mmhg or diastolic blood pressure \>90mmhg. * evidence of renal impairment - calculated creatinine clearance \<60ml/min or clinically relevant finding on urinalysis. * history of drug or other allergy which, in the opinion of the doctor, makes the subject unsuitable for participation in the study.

Keywords: gw274150 nitric oxide acute migraine
comparison of three meshes in lichtenstein hernia repair

Conditions: Chronic Pain; Recurrences

Summary: chronic pain may be a long-term problem after inguinal lichtenstein hernioplasty. the aim of this study was to compare long-term results of hernioplasty using three different meshes (partly absorbable, lightweight polypropylene and thick polypropylene mesh).

inguinal hernioplasty was performed under local anesthesia in 300 patients in day-case surgery by the same surgeon and exactly by the same surgical technique. the patients were randomized to receive either a partly polypropylene-polyglactin mesh (vypro ii, 100 hernias), a lightweight polypropylene mesh (premilene lp, 100 hernias) or a conventional densely woven polypropylene mesh (premilene, 100 hernias). pain, patients discomfort and recurrences of hernias were carefully followed 5 years after surgery.

Eligibility criteria:
inclusion criteria: * uni-or bilateral primary or recurrent inguinal hernia * patients age \>18yrs exclusion criteria: * previous mesh hernioplasty * femoral hernia * emergency operation * allergy to polypropylene

Keywords: inguinal hernia, lichtenstein hernioplasty, chronic pain
evoke data collection study germany

Conditions: Chronic Pain

Summary: the objective of this multicentre study is to collect electrophysiological and device data from the evoke closed-loop scs system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use.


Eligibility criteria:
inclusion criteria: * patient approval for data collection and transfer of de-identified data to sponsor. exclusion criteria: * no further exclusion criteria.
a study to describe the experience of both patients and their clinicians in the treatment of fabry disease with enzyme replacement therapy.

Conditions: Fabry Disease

Summary: this is an international, non-interventional research study of adult patients with fabry disease and their caregivers. the study comprised a prospective time and motion evaluation and a cross-sectional evaluation of patient and caregiver-reported outcomes. the study evaluated the time associated with the preparation and administration of a single dose of enzyme replacement therapy (ert) in patients by health care providers as well as the impact on fabry patients and caregivers time and costs associated with an ert treatment. the study also evaluated the patients' quality of life wellbeing, fatigue and work productivity.


Eligibility criteria:
patient inclusion criteria: * patients with a documented diagnosis of fabry disease (fd) * patients who have received ≥4 doses of ert (with agalsidase alfa or agalsidase beta) for the treatment of fd. * patients who present to the participating hospital(s) or treatment centre(s) for administration of a dose of ert (as part of their routine treatment) during the data collection period. caregiver inclusion criteria: -self-identifies as a caregiver of a patient with fd for whom written informed consent has been obtained for inclusion in the study. patient exclusion criteria: * patients who are unable or unwilling to give consent for study participation. * patients whose ert preparation and administration takes place exclusively in the home setting with no healthcare professional (hcp) involvement in preparation of the infusion. * for the time and motion evaluation: patients whose ert is administered by a hcp who does not consent to be observed. caregiver exclusion criteria: - caregiver (and/or the patient with fd whom they support or care for) is unable or unwilling to give consent for study participation.
gastrointestinal functional outcome ivor lewis

Conditions: Oesophageal Cancer

Summary: this study focuses on the prevalence of functional complications and their impact on qol in patients who underwent an ivor lewis oesophagectomy. this study will assess the prevalence of gastrointestinal symptoms and qol from beyond the first year following surgery up to 5 years. the aim is to determine whether gastrointestinal side effects and qol are compromised in the long-term. this study will also explore in details, the impact of surgery on their quality of life and gastro intestinal symptoms that patients has experienced post operatively.

oesophago-gastric (og) cancer is the fifth most common malignancy in the united kingdom, affecting approximately 16,000 people each year. although surgery offers the best prospect for potential cure of og cancers, radical treatment may result in increased treatment relate mortality, high treatment-induced morbidity, and reduced quality of life. traditionally, many centres managing og cancers focused on mortality and morbidity as their key outcome measures. however, a growing body of opinion considers that a measure of broader effects of ill health and treatment on the patients quality of life (qol) is necessary. such considerations are important as it is questionable if patients are subjected to treatment merely to offer them a few extra months of life, particularly if this is at the expense of quality of life. these includes physical, functional, social and physiological aspects of life. more than half of the operated patients will develop significant functional disorder after surgery affecting qol. the most common problems observed are dysphagia, dumping syndrome, delayed gastric emptying, and reflux. these functional disorder are not always detected immediately post operatively, but may become more troublesome as time goes by. the purpose of this study is * to evaluate mid to long term hrql in patients that underwent ivor lewis esophagectomy (ile) with gastric pull-up in royal leicester infirmary with minimum of 12 months follow up and up to 5 years. * to identify clinical factors influencing quality of life post operatively. * explore patients' experiences of their quality of life and how they handle their new life situation from a long-term perspective after oesophagectomy the outcome of this study would benefit both surgeons and patients in terms of pre-operative counselling and planning.

Eligibility criteria:
inclusion criteria: * patients who underwent ivor lewis oesophagectomy in leicester royal infirmary with minimum follow up of 12 months. * age more than 18 exclusion criteria: * disease recurrence within the follow up period * age less than 18
postoperative delirium - european society of anaesthesiology survey

Conditions: Postoperative Delirium

Summary: the esa is currently preparing a guideline on the management of postoperative delirium (pod), which attempts to reduce the impact of postoperative delirium and provide recommendations for prevention, diagnostics and treatment of delirium outside the intensive care unit. the guidelines are going to be published during 2015. while the guideline provides recommendations for daily practice, assessment of current practice and knowledge is of utmost importance, because the implementation and the measurement of a change in clinical practice will be dependent on these measurements. this survey has been approved by the scientific and research committees of the european society of anaesthesiology (esa), the media committee of the esa, as well as the institutional ethical committee of charité - universitätsmedizin berlin.


Eligibility criteria:
inclusion criteria: * anaesthesists, nursing staff, which are invited to the online - survey of the european society of anaesthesiology
effects of moderate-intensity interval training (miit) on mental toughness, sports motivation, athlete burnout, perceived stress, unforced errors and performance of competitive badminton players in china

Conditions: Burnout，Motivation，Stress，Mental Toughness

Summary: the objective of this observational study was to assess whether moderate intensity training (miit) intervention has positive effects on mental toughness, sports motivation, athlete burnout and perceived stress of badminton players in yunnan province. and reduce the error rate of badminton players


Eligibility criteria:
inclusion criteria: * 1. participants were between the ages of 18 to 30 2. male or female 3. at least 3 years' experience in amateur badminton training. this includes current players who are training with the province badminton team. or has been selected by the kunming badminton team in yunnan province. or have participated in domestic or foreign provincial, municipal or higher's competitions. exclusion criteria: - 1. participants who are currently injured. 2. participants who have not participated in any provincial badminton competition. 3. participants who refuse to give consent to participate in the study.

Keywords: burnout，motivation，stress and mental toughness of badminton players
knee osteoarthritis and balneotherapy

Conditions: Knee Osteoarthritis

Summary: the goal of this clinical trial is to assess the efficacy of a 18-day balneotherapy program in the rheumatology indication in patients presented with knee osteoarthritis. the main questions of the study aims to answer are how balneotherapy improves functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients' quality of life. participants are randomly assigned in control or treatment (spa) groups. all receive standard of care for knee osteoarthritis throughout the study. balneotherapy program consists of 18-days of spa treatment with mineral water of saint jean d'angely. functional incapacity, disorders and quality of life induced were measured at baseline and then 6 months later. variation from baseline were compared in control and treatment groups to assess the efficacy of the balneotherapy program.


Eligibility criteria:
inclusion criteria: * knee osteoarthritis with kellgren and lawrence stage 2 to 4 evidenced by a knee x-ray examination in the past 3 years); * 100-normalized score of the womac physical function subscale of 30 or greater; * available for balneotherapy program and the 6-month study follow-up; * signed inform consent; * with health insurance affiliation. exclusion criteria: * presented with balneotherapy contra-indication; * having had spa treatment in the past 6 months or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months; * presented with chronic pain other than osteoarthritis, with scheduled surgery related to knee osteoarthritis; * regulatory reason (guardianship or already enrolled in a clinical trial).

Keywords: balneotherapy, osteoarthritis
primary tube versus trabeculectomy study

Conditions: Glaucoma

Summary: the purpose of the primary tube versus trabeculectomy (ptvt) study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin c in eyes that have not had previous ocular surgery.


Eligibility criteria:
inclusion criteria: * age 18-85 years * glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure (iop) greater than or equal to 18 mm hg and less than or equal to 40 mm hg * no previous incisional ocular surgery exclusion criteria: * unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits * pregnant or nursing women * no light perception vision * active iris neovascularization or active proliferative retinopathy * iridocorneal endothelial syndrome * epithelial or fibrous ingrowth * chronic or recurrent uveitis * steroid-induced glaucoma * severe posterior blepharitis * unwilling to discontinue contact lens use after surgery * previous cyclodestructive procedure * conjunctival scarring from prior ocular trauma or cicatrizing disease precluding a superior trabeculectomy * functionally significant cataract * need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery

Keywords: tube shunt surgery trabeculectomy
cold snare endoscopic mucosal resection trial

Conditions: Colonic Polyp; Colonoscopy; Complication; Recurrence

Summary: this study compares different approaches to endoscopic mucosal resection (emr) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. the first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare emr) and half of patient to polyp resection without electrocautery ("cold" snare emr). the second randomization will assign half of patients to polyp removal using eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.

electrocautery, or hot snare resection has long been considered the standard approach to polyp resection. a major limitation is a 5 to 10% risk of major adverse events. recent studies suggest that snare resection without electrocautery - so-called cold snare emr - may be safer than hot snare emr. the concern with cold snare resection is a potentially lower efficacy, because cold snare resection requires the removal of a large polyp in smaller and greater number of pieces than with hot snare resection. this may lengthen procedure time and increase the risk of incomplete resection. furthermore, there is uncertainty about the optimal injection solution for lifting of the polyp prior to resection. normal saline with methylene blue as the contrast agent is frequently used, but is limited by fast dissipation of the polyp lift. eleview is a newly approved viscous solution (that contains methylene blue), which provides a longer polyp lift than normal saline. it is unclear how these two solutions compare with respect to resection efficacy and safety.

Eligibility criteria:
inclusion criteria: * any patient ≥18 who presents for a colonoscopy and who does not have criteria for exclusion * patients with a ≥20mm non-pedunculated colorectal polyp exclusion criteria: * pedunculated polyps (as defined by paris classification type ip) * suspected adenocarcinoma with deep submucosal invasion * patients with ulcerated depressed lesions (as defined by paris classification type iii) or confirmed adenocarcinoma * patients with inflammatory bowel disease * patients who are receiving an emergency colonoscopy * poor general health (asa class\>3) * patients with coagulopathy with an elevated inr ≥1.5, or platelets \<50 * inadequate bowel preparation (boston bowel prep scale, total score ≤2) * pregnancy
zd 1839 in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: some tumors need growth factors produced by the body's white blood cells to keep growing. drugs such as zd 1839 may interfere with the growth factors and cause tumor cells to die. purpose: phase ii trial to study the effectiveness of zd 1839 in treating patients who have metastatic kidney cancer.

objectives: i. determine the efficacy of zd 1839 in patients with metastatic renal cell cancer. ii. determine the time to disease progression in patients treated with this drug. iii. determine the safety of this drug in these patients. outline: patients receive oral zd 1839 once daily. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed for at least 1 month. projected accrual: a total of 16-46 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: histologically confirmed metastatic renal cell carcinoma bidimensionally measurable disease bone metastasis as only site must have at least 1 bidimensionally measurable tissue mass by ct or mri (e.g., expansile lesion) radiologic evidence of disease progression or symptoms related to disease no brain metastases patient characteristics: age: not specified performance status: karnofsky 70-100% life expectancy: more than 3 months hematopoietic: wbc at least 3,000/mm3 absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 1.5 mg/dl alt/ast no greater than 2.5 times upper limit of normal (uln) renal: creatinine no greater than 1.5 times uln other: no prior malignancy within the past 5 years unless potentially curatively treated or deemed at low risk for recurrence not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: at least 4 weeks since prior biologic therapy and recovered no more than 1 prior biologic regimen no other concurrent biologic therapy chemotherapy: at least 4 weeks since prior cytotoxic therapy and recovered no more than 1 prior cytotoxic regimen no concurrent cytotoxic therapy endocrine therapy: at least 4 weeks since prior hormonal therapy and recovered no more than 1 prior hormonal regimen no concurrent hormonal therapy radiotherapy: at least 4 weeks since prior radiotherapy no concurrent radiotherapy surgery: at least 4 weeks since prior major surgery

Keywords: stage iv renal cell cancer recurrent renal cell cancer
a study to learn about the safety of talzenna in people with prostate cancer.

Conditions: Prostate Cancer

Summary: the purpose of this study is to learn about the safety of talzenna in patients with brca mutation-positive metastatic castration-resistant prostate cancer. brca mutation positive means any changes to the brca gene. metastasis means the cancer that has spread to other parts of the body. castration-resistant prostate cancer means the prostate cancer that keeps growing even when the amount of male sex hormone in the body is reduced to very low levels. prostate is a male sex organ. the study is seeking for participants: * with brca mutation-positive metastatic castration-resistant prostate cancer * who have not used this study medicine before. all patients in this study will receive talzenna according to the prescriptions. patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (day 1). however, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.


Eligibility criteria:
inclusion criteria: * patients with brca mutation-positive metastatic castration-resistant prostate cancer * no history of previous use of this drug exclusion criteria: * none

Keywords: brca mutation-positive metastatic castration-resistant prostate cancer
ocular development and refractive error changes among children and adolescent - a longitudinal study

Conditions: Myopia

Summary: the study aims to observe the ocular development and refractive error changes among school children and adolescents

this study aims to observe the refractive error changes of school children and adolescents for 3 years, and to collect data of ocular structural parameters, family history and environmental factors so as to understand the natural course and internal laws of myopia progression.

Eligibility criteria:
inclusion criteria: * school children and adolescent at the age of 3(junior kindergarten), 6(grade 1), 9(grade 4), 12(grade 7). * no allergy to tropicamide or topical anesthetics * written informed consent is obtained from guardian * be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire. exclusion criteria: * no history of eye diseases * receiving or has been received treatment of myopia control such as atropine eye drops, corneal contact lens or myopic glasses * a history of allergy to topic amide or topical anesthetics * have severe systemic disease * missing ability to give informed consent

Keywords: refractive error ocular structural parameters